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新型化学皮肤腐蚀试验评估。

Evaluation of a New In Chemico Skin Corrosion Test.

机构信息

Lebrun Labs LLC, 3301 E. Miraloma Ave., Ste. 194, Anaheim, CA 92806, USA.

Lebrun Labs LLC, 3301 E. Miraloma Ave., Ste. 194, Anaheim, CA 92806, USA.

出版信息

Toxicol In Vitro. 2024 Dec;101:105944. doi: 10.1016/j.tiv.2024.105944. Epub 2024 Sep 26.

DOI:10.1016/j.tiv.2024.105944
PMID:39341469
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11737548/
Abstract

The purpose of this study is to evaluate a novel macromolecular test method for the identification of dermal corrosives. The simple in chemico test procedure involves allowing the material to be tested to interact with a skin biomarker for corrosivity and then adding a detection reagent. The corrosivity of the test substance is predicted based on the measured macromolecular damage, which results in reduced optical density of the detection reagent as compared with controls. This study aims to determine if such an extremely simple, cell-free test method can accurately identify dermal corrosives. To determine predictivity and repeatability, we tested 60 chemicals (30 in vivo dermal corrosives and 30 in vivo dermal noncorrosives; all tested in triplicate) representative of a broad range of chemical classes, functional groups, mixtures, and levels of toxicity. Validation results indicate the GHS multicategory and packing group assignment accuracy is on par with that of the Reconstructed Human Epidermis test method and the Membrane Barrier test method and for the global identification of corrosives, the method has a considerably higher accuracy (98 % vs. ∼80 %).

摘要

本研究旨在评估一种新型的大分子测试方法,用于鉴定皮肤腐蚀性物质。该方法在化学方面的测试程序非常简单,只需让待测试的物质与皮肤腐蚀性生物标志物相互作用,然后添加检测试剂。根据所测量的大分子损伤,预测测试物质的腐蚀性,与对照相比,检测试剂的光密度降低。本研究旨在确定如此简单、无细胞的测试方法是否能够准确识别皮肤腐蚀性物质。为了确定预测性和可重复性,我们测试了 60 种化学物质(30 种体内皮肤腐蚀性物质和 30 种体内皮肤非腐蚀性物质;均重复测试 3 次),代表了广泛的化学类别、功能基团、混合物和毒性水平。验证结果表明,GHS 多类别和包装组的分配准确性与重建人体表皮测试方法和膜屏障测试方法相当,并且该方法对腐蚀性物质的全球识别具有更高的准确性(98%比约 80%)。

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本文引用的文献

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FDA Modernization Act 2.0 allows for alternatives to animal testing.《美国食品药品监督管理局现代化法案2.0》允许采用动物试验的替代方法。
Artif Organs. 2023 Mar;47(3):449-450. doi: 10.1111/aor.14503. Epub 2023 Feb 10.
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Further optimisation of a macromolecular ocular irritation test (OptiSafe).进一步优化大分子眼部刺激性试验(OptiSafe)。
Cutan Ocul Toxicol. 2023 Mar;42(1):38-48. doi: 10.1080/15569527.2023.2170067. Epub 2023 Jan 28.
3
Expansion of the application domain of a macromolecular ocular irritation test (OptiSafe™).拓展高分子眼部刺激性试验(OptiSafe™)的应用领域。
Toxicol In Vitro. 2023 Feb;86:105515. doi: 10.1016/j.tiv.2022.105515. Epub 2022 Nov 6.
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Suffering in Animal Research: The Need for Limits and the Possibility of Compensation.动物研究中的痛苦:限制的必要性和补偿的可能性。
Kennedy Inst Ethics J. 2022;32(3):297-311. doi: 10.1353/ken.2022.0019.
5
Ascorbic acid specifically reduces the misclassification of nonirritating reactive chemicals in the OptiSafe™ macromolecular eye irritation test.抗坏血酸可特异性降低 OptiSafe™ 高分子量眼刺激性试验中对非刺激性反应性化学物质的错误分类。
Toxicol In Vitro. 2022 Apr;80:105313. doi: 10.1016/j.tiv.2022.105313. Epub 2022 Jan 13.
6
ChemSkin Reference Chemical Database for the Development of an In Vitro Skin Irritation Test.用于体外皮肤刺激性试验开发的ChemSkin参考化学数据库。
Toxics. 2021 Nov 18;9(11):314. doi: 10.3390/toxics9110314.
7
Modeling the antioxidant properties of the eye reduces the false-positive rate of a nonanimal eye irritation test (OptiSafe).对眼部抗氧化特性进行建模可降低非动物眼刺激性试验(OptiSafe)的假阳性率。
Toxicol In Vitro. 2021 Oct;76:105208. doi: 10.1016/j.tiv.2021.105208. Epub 2021 Jun 30.
8
Same-chemical comparison of nonanimal eye irritation test methods: Bovine corneal opacity and permeability, EpiOcular™, isolated chicken eye, ocular Irritection®, OptiSafe™, and short time exposure.非动物眼刺激性试验方法的同化学比较:牛角膜混浊和通透性、EpiOcular™、鸡眼离体、眼刺激性检测试剂盒、OptiSafe™和短时间暴露。
Toxicol In Vitro. 2021 Apr;72:105070. doi: 10.1016/j.tiv.2020.105070. Epub 2020 Dec 19.
9
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Toxicol In Vitro. 2019 Feb;54:147-167. doi: 10.1016/j.tiv.2018.09.015. Epub 2018 Sep 26.
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Burns. 2017 May;43(3):654-664. doi: 10.1016/j.burns.2016.08.037. Epub 2016 Sep 28.